FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIXATION INSTRUMENTS
K Number: K863727
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
5
Review Days
38
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FIXATION INSTRUMENTS
- K Number
- K863727
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Technology Development Corp.
- Date Received
- September 23, 1986
- Decision Date
- October 31, 1986
- Product Code
- HNR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNR), ordered by most recent decision date.
STEPHENS DISPOSABLE FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
ALCON FOLDING FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
SOFT LENS FOLDING BLOCK
FDA 510(k)
FDA Class 1
·Ophthalmic
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
FDA 510(k)
FDA Class 1
·Ophthalmic
MCDONALD FOLDING FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
BRADBURY INTRAOCULAR RETINAL KIT CAT #200
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Medical Technology Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | Nov 30, 1994 | Substantially Equivalent |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Jan 7, 1987 | Substantially Equivalent |
| K863725 | CATARACT DIAMOND KNIFE | Oct 31, 1986 | Substantially Equivalent |
| K863726 | INSTRUMENT STERILIZATION TRAY | Oct 14, 1986 | Substantially Equivalent |